Burn Pit Exposure in Veterans: A Cancer Screening Pilot Study at the Inova Saville Cancer Screening & Prevention Center

NCT07485322 | Not Yet Recruiting FDA Device

• 1 other identifier: INOVA-2025-302
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine the feasibility and participant satisfaction associated with a more intensive cancer screening regimen in veterans exposed to burn pits. The study results may describe the clinical and psychosocial impact such screening has on this potential population. The study hopes to share the premalignant and malignant findings identified and follow-up healthcare utilization associated with high-intensity cancer screening during the approximately 3-year study period (three annual screening assessments and an additional year of follow-up to determine participants' cancer status). The study will also explore the performance of new tools (nasal brush, multi-cancer detection blood test, and radiomic analysis) in detecting the development of cancer during the study period.

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

• STAI Questionnaire

  Participant Satisfaction and psychosocial impact of cancer screening will be measured by the Anxiety and Satisfaction Survey. The STAI is a validated anxiety tool that has been used in a variety of research and clinical settings, including studies of cancer screening. The survey will be administered at the following timepoints: After enrollment, before each of the up to 8 screening procedures, after each screening procedure, and after the 1 year screening period. The state component of the questionnaire will be administered at the following timepoints: 12-month study visit, 24-month study visit, before each of the up to 8 screening procedures, after post results review from the previous screening assessment, and follow up (1 year + 2 months following the last screening assessment). STAI scores are computed on a scale from 20-80, with higher scores representing a higher degree of anxiety.

  3.5 years

• Burn Pit Exposure Questionnaire

  This questionnaire will determine the demographic, clinical, lifestyle, and burn pit exposure characteristics of participants in the intensive cancer screening regimen. This questionnaire administered during baseline will assess the position, branch, and dates of military service for each participant and whether they were stationed, worked, and/or lived near a burn pit during those dates of service. The questionnaire will also include an assessment of the specific types of duties that the participant performed if working near the burn pit and how many hours they were exposed to smoke or fumes from the burn pit on a typical day. Participants' demographic, lifestyle and clinical, and burn pit exposure characteristics will be summarized using descriptive statistics

  1 day

• Cancer Outcomes Follow up Questionnaire

  This questionnaire will describe the number, proportion, and stage of confirmed pre-malignant and malignant findings in veterans exposed to burn pits during each annual screening period and during follow-up for the intensive cancer screening protocol. This questionnaire is completed at 12 (+ 2) months following the 24-month screening assessment by phone or electronically. This questionnaire will assess information on any new diagnoses of cancer since the last screening visit. This information can also be collected from medical records without direct participant contact instead of questionnaire if available within the timeframe. The number, proportion, and type and stage of confirmed cancers, and participant demographic, lifestyle, and clinical characteristics will be summarized using descriptive statistics.

  1 day

• Intensive Cancer Screening Feasibility

  Feasibility will be defined as 75% of enrolled participants completing at least 80% of the cancer screening assessments for which they are eligible during each screening period. Any adverse events resulting from the study procedures will be monitored by the research and clinical team during the study visits and will also be assessed during follow-up with participants when the results of screening examinations are provided. The assessments include: * Laboratory assessments (CBC, CMP, TSH, LDH, PSA, urinalysis) * ENT, skin (with Vectra), breast, and neurological exams * Pulmonary function test (PFT) * Flexible Laryngoscopy * Stool-based colon cancer screening (age 35-44 years) * Mammogram (women age 35-39) * Low-dose CT scan of the chest * Brain MRI with contrast (only for those with abnormal neuro exam) * Testicular ultrasound

  2 years

Secondary Outcomes (3)

• Nasal Swab

  1 day

• Blood Collection - Multi-cancer detection Blood Test

  3 years

• Radiomic analysis

  2 years

Study Arms (1)

Veterans exposed to burn pits

EXPERIMENTAL

Veteran of the United States Armed Forces (retired/no longer enlisted) with a prior deployment resulting in exposure (based on self-report or official records, if available) to burn pits for \>1 week (exposure defined as on the base or close enough to the base to see the smoke from the burn pit, an area of land used for the open-air combustion of trash and other solid waste products).

Device: Avantect Multi-Cancer Detection Test; Diagnostic Test: Nasal Swab

Interventions

Avantect Multi-Cancer Detection Test DEVICE

Multi-cancer blood test to detect cancer DNA. Manufactured by ClearNote Health.

Also known as: MCD

Veterans exposed to burn pits

Nasal Swab DIAGNOSTIC_TEST

Two nasal brush swabs will be collected during the baseline screening period. The brushing of the inside of the nose is performed using a soft brush, with local anesthetic if necessary.

Veterans exposed to burn pits

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 35 years
• Veteran of the United States Armed Forces (retired/no longer enlisted) with a prior deployment resulting in exposure (based on self-report or official records, if available) to burn pits for \>1 week (exposure defined as on the base or close enough to the base to see the smoke from the burn pit, an area of land used for the open-air combustion of trash and other solid waste products).
• Ability to understand and willing to sign informed consent
• Ability to understand and willing to sign HIPAA Authorization

You may not qualify if:

• No history of malignancy within the past 5 years (non-melanoma skin cancer and in situ carcinoma would still be eligible) and not currently being worked up clinically for suspicion of cancer.
• For women of childbearing potential, not pregnant.

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Related Links

• US Dept of Veterans Affairs: Airborne Hazards and Burn Pit Exposures
• US EPA: Health and environmental effects of particulate (PM)
• US EPA: Integrated Science Assessment for Particulate Matter
• American Cancer Society: Military Burn Pits and Cancer Risk
• US CDC: HPV and Oropharyngeal Cancer

MeSH Terms

Conditions

Neoplasms

Study Officials

• Rebecca Kaltman, MD

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

• Stephanie VanBebber

  Inova Health Care Services

  STUDY DIRECTOR

Central Study Contacts

Bryan Bassig, PhD

CONTACT

(571) 472-3500; bryan.bassig@inova.org

Salman Baig

CONTACT

(571) 472-3500; salman.baig@inova.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 20, 2026
• Study Start: May 2, 2026
• Primary Completion (Estimated): April 28, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)